Device for treating infants having breathing difficulties

ABSTRACT

A device for treating infants having breathing difficulty has a rigid, externally grooved ring to one side of which is attached a clear, flexible, plastic envelope adapted to contain the infant&#39;&#39;s head and provided with a connection for a flexible hose leading breathing gas under pressure from a suitable source into the envelope. The other side of the ring is spanned by a flexible, plastic diaphragm overlying the groove and held in engagement with the ring by a quickly removable contracting band deforming the diaphragm material into the groove. The diaphragm has an opening therein encircled by a collar adjustable into close contact with the infant&#39;&#39;s neck. The envelope has a slider-closed major access opening and various fittings for minor access and monitoring connections.

[ DEVICE FOR TREATING INFANTS HAVING BREATHING DIFFICULTIES [75]Inventor: Sotiris Kitrilakis, Berkeley, Calif.

[73] Assignee: Teena Corporation, Emeryville,

Calif.

[22] Filed: Sept. 7, 1972 [21] Appl. No.: 286,968

[52] US. Cl. 128/191 [51] Int. Cl A61m 16/02 [58] Field of Search...128/19] R, 191 A, 1 B, 204, 128/202, 203, 185, 145.5, 140, 142, 142.3,

FOREIGN PATENTS OR APPLICATIONS 226,883 10/1910 Germany 128/1423 PrimaryExaminer-Richard A. Gaudet Assistant Examiner-Henry .l. Recla Attorney,Agent, or Firm-Lothrop & West 5 7 ABSTRACT A device for treating infantshaving breathing difficulty has a rigid, externally grooved ring to oneside of which is attached a clear, flexible, plastic envelope adapted tocontain the infants head and provided with a connection for a flexiblehose leading breathing gas under pressure from a suitable source intothe envelope. The other side of the ring is spanned by a flexible,plastic diaphragm overlying the groove and held in engagement with thering by a quickly removable contracting band deforming the diaphragmmaterial into the groove. The diaphragm has an opening therein encircledby a .collar adjustable into close contact with the infants neck. Theenvelope has a slider-closed major access opening and various fittingsfor minor access and monitoring connections.

8 Claims, 8 Drawing Figures DEVICE FOR TREATING INFANTS HAVING BREATHINGDIFFICULTIES In recent years there has been considerable progress intreating difficulties occurring, particularly in newly born infants andwhich inhibit their proper breathing. The difficulties are sometimesreferred to as hyaline membrane disease and sometimes referred to asidiopathic respiratorydistress syndrome. Some newly born infants,especially infants of very small size and premature, have substantialdifficulty in breathing, to the extent that there is severe mortalityfrom this cause. Various treatments of the difficulty have been proposedand utilized with different degrees of success. Recently, an advance hasbeen made in connection with a treatment process utilizing a supply ofbreathing gas, primarily air and oxygen administered to the infant undersuperatmospheric pressure for a protracted period; for exampie, from sayone to about fourteen days. Germane reports are Treatment of theIdiopathic Respiratory- Distress Syndrome With Continuous PositiveAirway Pressure" by George A. Gregory et al. published in the NewEngland Journal of Medicine, 284:1333-1340 (June 17), 1971, and PuttingPressure On Hyaline, Medical World News for Jan. 14, 1972, pages 2732.

It is therefore an object of the invention to provide a device fortreating infants with breathing difficulty in a successful andeconomical fashion.

Another object of the invention is to provide such a device which doesnot substantially interfere in any way with the normal care andtreatment of the infant.

A further object of the invention is to provide such a treating devicewhich can readily be accommodated to different infants.

Another object of the invention is to provide such a device that canquickly and easily be removed from the infant in the event of anemergency.

A further object of the invention is to provide an economical devicethat can be utilized for one individual and then discarded.

A further object of the invention is to provide such a device that isreadily stored and is easily portable.

A further object of the invention is to provide a device for treatinginfants which can easily be accommo dated to variations in care requiredby individual infants.

Other objects together with the foregoing are attained in the embodimentof the invention described in the accompanying description andillustrated in the accompanying drawings, in which:

FIG. 1 is a side elevation of a device in actual use;

FIG. 2 is a plan of the device, portions being broken away;

FIG. 3 shows part of the device near the ring;

FIG. 4 is an enlarged cross-section on the line 4-4 of FIG. 3;

FIG. 5 is a partly sectioned elevation showing a backing plate;

FIG. 6 is an elevation of the backing plate;

FIG. 7 is a cross-section of a modification; and

FIG. 8 is an elevation of part of the FIG. 7 device.

While the device can be embodied in various different configurations andsizes for adults as well as infants and can be used in a number ofwidely differing ways, it has with considerable success been embodiedespecially for infants as illustrated herein. In this instance thedevice is primarily used in connection with a support 6 such as a tableor bed or crib on or within which the infant 7 can lie. Adapted to restlightly on the sup port 6 and to establish an upright, frame'likestructure is a ring 8 (See FIG. 7). Conveniently, this is fabricated ofa clear plastic material and preferably has an elliptical shape such aswould result from cutting the ring obliquely from a circular tube. Theinterior surface 9 of the ring is circular cylindrical, as is theexterior sur face 11, except that circumscribing the ring exterior is agroove 12 half-circular in cross-section.

Secured to the ring by any suitable means, such as an adhesive or byheat sealing, is an envelope 13 conveniently fabricated of one or twosheets of transparent, flexible plastic material of any suitableconfiguration and preferably secured in edge-closed form by aperipheral, adhesive or heat seal margin 14. The plastic is flexibleenough so that it can diverge from an initial, relatively flatcondition, particularly at one end, to the generally elliptical shape ofthe ring 8 where the envelope and ring join.

, Also adapted to engage the ring 8 is a diaphragm 16 of very soft,flexible, plastic material of a size that can easily span the ring andoverlie the surface 11, particularly the groove 12. The diaphragm isheld in tight engagement with the ring and is quickly attachable theretoand detachable therefrom by use of a contracting band 17. This isconveniently of an elastomeric plastic or rubber. It is of circularcross-section and, when relaxed, is of slightly less extent than thering. The diaphragm is first stretched over the ring, and the band isthen enlarged momentarily, arranged around the ring and then relaxed andseated in the groove with the diaphragm intervening. A close, virtuallyair-tight connection is thus made, but, if desired, the band can quicklyand easily be withdrawn from the groove and the diaphragm freed from thering.

The diaphragm, as particularly shown in FIGS. 3 and 4, has an opening 18therethrough of generally circular configuration. The opening 18 is topass the head of the infant and then circumscribe the infants neck andmake a relatively air-tight abutment therewith. To that end thediaphragm 16 is provided with a pair of side rings I9 and 21 of quitesoft, flexible plastic. Around their outer peripheral edges 22 the siderings are both heat sealed to the material of the diaphragm. At theirinner peripheral edges 23 the side rings are heat sealed to a continuoustubular strip 24 of similar, very soft plastic. The side rings and thestrip constitute a deformable and inflatable annulus. Leadking into thechamber 26 defined by the annulus is an air tube 27 having a suitableclosure valve 28 or knot therein.

The envelope 13 is provided with a number of devices for facilitatingits use. Extending for a large fraction of the length of the envelope onthe upper side thereof is a slide closer 31 having a slider 32 thereon.The closer preferably has continuous margins with airtight interleavingwhen closed. When opened by manipulation of the slider 32 the resultingcloser opening is large enough to receive the hand or hands of anattendant and to afford adequate access to the head of the infant.

Also passing through the material of the envelope are closable accessfittings 33 and 34 with integrally formed, tightly engaging caps 36thereon. Usually but one of the fittings 33 and 34 is utilized at atime, but they are both provided for ease in connecting adjacentequipment. When not in use the closed caps 36 are air- 3 tight. One ofthe fittings; for example, the fitting 33, is connected tightly to aflexible hose 37 extending to a source 38 of breathing gas for theinfant.

In most instances the breathing gas is supplied from a source of suchgas at superatmospheric pressure. The pressure furnished is subject toregulation by a controller 39. To monitor the instantaneous pressure,the envelope is also provided with a tubular fitting 41 having adetachable closure cap 42. A tube 43 is attached to the fitting 41 fortransmitting the pressure within the enclosure to the breathing gassource 38. For convenience in displaying the interior pressure theenvelope also has a fitting 44 connected by a tube 46 to a suitablegauge 47. An attendant, even at a remote location, can observe thepressure and pressure variations within the envelope. In addition, thereis afforded a closable fitting 48 having a displaceable top 49 so thatparticular implements, such as tubes or thermometers, can be introducedto the envelope in the general vicinity of the mouth and nose of theinfant. Gas discharge can be by leakage or through one of the fittingsat a rate to maintain the desired envelope pressure.

In the use of the device, the diaphragm can be assembled as described onthe ring and with the envelope. When the chamber 26 is uninflated theinfants head can be introduced through the opening 18 into the interior.Since the material of the diaphragm is extremely soft and deformable,there is no difficulty in doing so. Alternatively, the diaphragm in alimp, unattached condition can be first put over the infants head andcan come to rest around the infants neck. The diaphragm can subsequentlybe secured to the ring by subsequent attachment of the band 17.

In any case, when the opening 18 loosely encircles the infants neck, thevalve 28 is opened and a slight pressure is introduced into the chamber26 through the tube 27. The chamber is thus deformed from its flaccid,relaxed state into an inflated annulus of decreased internal diameter.The wall 24 lies against the skin of the infants neck and makes a closeabutment therewith. Since there is no seam in the wall 24, there is nolikelihood of any injury to the infants skin. The pressure within thechamber 26, even though slight, is sufficient to ensure either a verymoderate, planned leakage between the wall 24 and the infants neck orsubstantially no leakage at all. The flexibility of the diaphragm and ofthe associated annulus is such that the infant can move with respect tothe apparatus or can be moved with respect to it without any specialstrain or force being exerted and certainly without any injury to theinfant.

The envelope is put into a closed condition by operation of the slider32 and connection of the various tubes 43 and 46 and particularly of thetube 37. The closures 36 and 49 that are not in use are snapped shut.The envelope is thus substantially sealed hermetically. By operation ofthe regulator 39, a regulated supply of breathing gas is furnishedthrough the tube 37 and inflates the interior of the envelope. This thentakes on a shape different from its collapsed, relatively flat shape andarrives at a configuration substantially as shown in the figures, sothat the envelope is away from any contact with the babys face and atleast most of its head. Should the air pressure at any time suddenlyfail and the envelope not be subject to internal pressure, the extent,position and stiffness of the ring 8 are sufficient so that the plasticenvelope cannot fall into contact with the babys face and obstruct itsbreathing.

By observing the gauge 47 and by regulating the controller 39, there canbe supplied to the infant a continuous or pulsating stream of breathinggas at a superatmospheric pressure. This is effective, as and to theextent set forth in the publications above noted, to foster thecontinued existence of the infant and drastically to redice themortality otherwise occurring.

In some instances the apparatus is slightly modified by the provision ofan intermediate humidifying attach ment 51 in the tube 37. Theattachment is supplied with moisture through a tube 52 and affords thedesired humidity within the envelope.

It is intended that the infant reside in the envelope for a period ofseveral days. To permit the infant to be cared for during that time, theslider 32 is intermittently moved to afford an opening. From time totime the fitting 48 can be utilized for a feeding tube, for otherintubation, for thermometric measurement and the like.

When the infant is able to live outside of the envelope, it is a simplematter to remove the various attachments, remove the band 17 to detachthe membrane, deflate the chamber 26 so that the opening 18 enlarges,and to withdraw the membrane and envelope from the infant. The plasticportion of the structure; that is to say, the ring, the diaphragm andthe envelope, can be appropriately sterilized for reuse or areeconomical enough so that they can be completely discarded.

It is sometimes the case that the diaphragm 16 is so soft that theinternal pressure causes excessive external bulging. To prevent this andto serve as an additional stabilizer, there is provided, as shown inFIGS. 5 and 6, a stiff plastic baking plate 61. This has three rolled orinturned edges forming flanges 62, 63 and 64 arranged frictionally toengage end overlie the adjacent positions of the assembled ring 8 andband 17. The plate 17 has an inverted U-shaped cut-out portion 66 ofadequate extent to pass the infants neck.

When the parts are otherwise assembled, the backing plate 61 is slippedinto position, as shown in FIG. 5, and underlies the diaphragm 16. Thediaphragm under pressure deforms against the backing plate and issupported even against large internal pressure. Even so, the backingplate can be quickly removed from the ring 8 for emergency disassembly.

If the pneumatic annulus around the infants neck is not desired, it ispossible to substitute an arrangement as shown in FIGS. 7 and 8 In thisinstance, the ring 8 and contracting band are as before but retain asoft rubber diaphragm 71 generally like the diaphragm l6 and used with abacking plate 61 if desired. The diaphragm 71 is formed with a slightlyconical soft rubber, preferably integral, collar 72 having a size onlyslightly larger than the infants neck. A range of collar sizes is madeavailable. The diaphragm 71 is slipped over the infants head until thecollar is properly positioned around the infants neck. This alone mayafford a sufficiently close fit. But is is usually supplemented by astrip 73 of flexible material faced with hooks and loops, such as aVelcro fastener. One end of the strip 73 is secured to the collar 72.The other end of the strip, in use, is lapped over the secured end asfar as necessary to reduce the collar 72 to the proper neck size for theinfant.

With either apparatus an environment can be easily and quickly andeconomically furnished to alleviate breathing difficulties and toprovide an ambiance of selected pressure, moisture, temperature andquietness without interfering with easy observation, monitoring andcare.

What is claimed is:

1. A headenclosing, flexible envelope having an upper sheet and a lowersheet united on all sides but having a margin defining an opening at oneend, a rigid ring defining an aperture large enough to pass over apersons head, means for securing said margin to said ring around saidaperture, said ring being of a size to hold said upper sheet of saidun-inflated envelope away from the face of a persons head inside saidenvelope, a flexible diaphragm having an opening and having a margin anddisposed in position on said ring to span said aperture, means forholding the margin of said diaphragm on said ring, an annular membersecured to said diaphragm in a position surrounding said openingtherein, means for conforming said annular member to a persons necklocated in said diaphragm opening, and means effective when said annularmember surrounds a persons neck for inflating said envelope to move saidupper wall farther away from the face of a persons head inside saidenvelope.

2. A device as in claim 1 in which said ring is substantially ellipticaland defines an elliptical shape for the adjacent parts of said envelopeand said diaphragm engaged therewith.

3. A device as in claim 1 in which said annular member is a tube joinedto said diaphragm and having a relatively flat and continuous insidesurface, and means for inflating said tube.

4. A device as in claim 1 in which said envelope is made of flexiblematerial distensible substantially into a predetermined shape by thepressure of the gas supplied thereto by said supplying means.

5. A device as in claim I for use on a substantially horizontal surfacein which said ring has a lower supporting surface adapted to be disposedsubstantially horizontally and has side surfaces inclined to thehorizontal when said lower supporting surface is substantiallyhorizontal.

6. A device as in claim 1 including a rigid plate overlying the exteriorof said diaphragm, and means for removably engaging said plate and saidring.

7. A device as in claim 6 in which said plate includes means defining aU-shaped cut-out portion adapted to pass a persons neck.

8. A device as in claim 6 in which said ring and said plate are the onlyrigid supports for said envelope.

1. A head-enclosing, flexible envelope having an upper sheet and a lowersheet united on all sides but having a margin defining an opening at oneend, a rigid ring defining an aperture large enough to pass over aperson''s head, means for securing said margin to said ring around saidaperture, said ring being oF a size to hold said upper sheet of saidun-inflated envelope away from the face of a person''s head inside saidenvelope, a flexible diaphragm having an opening and having a margin anddisposed in position on said ring to span said aperture, means forholding the margin of said diaphragm on said ring, an annular membersecured to said diaphragm in a position surrounding said openingtherein, means for conforming said annular member to a person''s necklocated in said diaphragm opening, and means effective when said annularmember surrounds a person''s neck for inflating said envelope to movesaid upper wall farther away from the face of a person''s head insidesaid envelope.
 2. A device as in claim 1 in which said ring issubstantially elliptical and defines an elliptical shape for theadjacent parts of said envelope and said diaphragm engaged therewith. 3.A device as in claim 1 in which said annular member is a tube joined tosaid diaphragm and having a relatively flat and continuous insidesurface, and means for inflating said tube.
 4. A device as in claim 1 inwhich said envelope is made of flexible material distensiblesubstantially into a predetermined shape by the pressure of the gassupplied thereto by said supplying means.
 5. A device as in claim 1 foruse on a substantially horizontal surface in which said ring has a lowersupporting surface adapted to be disposed substantially horizontally andhas side surfaces inclined to the horizontal when said lower supportingsurface is substantially horizontal.
 6. A device as in claim 1 includinga rigid plate overlying the exterior of said diaphragm, and means forremovably engaging said plate and said ring.
 7. A device as in claim 6in which said plate includes means defining a U-shaped cut-out portionadapted to pass a person''s neck.
 8. A device as in claim 6 in whichsaid ring and said plate are the only rigid supports for said envelope.